Adipose Derived Stem Cells Transplantation for Chronic Obstructive Pulmonary Disease

Phase 1

• Conditions: COPD
• Interventions: Biological: Adipose derived stem cells

• Registration Number: NCT02645305
• Lead Sponsor: University of Science Ho Chi Minh City

Brief Summary

Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases including chronic bronchitis, emphysema and chronic obstructive airways disease. People with COPD have difficulties breathing, primarily due to the narrowing of their airways, this is called airflow obstruction.

Some preclinical evaluations showed that COPD is closely related to chronic inflammation; therefore, this study aimed to use adipose-derived stem cells (ADSCs) in the form of non-expanded culture - that usually names as a stromal vascular fraction (SVF) in combination with activated platelet rich plasma (PRP) to treat this disease. Both SVF and PRP are autologous sources that obtained from adipose tissue and peripheral blood, respectively. This mixture is intravenously transfused into the patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Status Verified: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-30
• Last Update Submitted: 2015-12-30
• Study First Posted: 2016-01-01
• Last Update Posted: 2016-01-01
• Primary Completion: 2016-09
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age 40 to 80, inclusive
• A prior diagnosis of moderate to severe COPD
• GOLD IIa, III, IV

Exclusion Criteria

• Pregnant or lactating
• Life expectancy < 6 months due to concomitant illnesses.
• Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
• Any illness which, in the Investigators judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of study results
• Subjects on chronic immunosuppressive or chemotherapeutic therapy
• Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
• Subjects with Alpha-1 antitrypsin deficiency (an inherited disorder that can cause lung disease and liver disease).
• Unwilling and/or not able to give written consent
• Patient is positive for hepatitis (past history of Hepatitis A is allowed)
• Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
• Cerebral aneurysm clips

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Adipose derived stem cells	Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be transfused into 20 COPD patients.

Primary Outcome Measures

Name	Time	Method
SGOT	1 month	The blood SGOT levels are thus elevated with liver damage
SGPT	1 month	The blood SGPT levels are thus elevated with liver damage

Secondary Outcome Measures

Name	Time	Method
6 min walk test	1 month, 6 months, 12 months
CRP concentration	6 months, 12 months	The CRP concentration in the patients were evaluated before and after treatment for 6 and 12 months
rates of panic attacks	1 month, 6 months, 12 months
Respiration rate	1 month, 6 months, 12 months

Trial Locations

Locations (3)

Van Hanh Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh; 🇻🇳 Ho Chi Minh, Vietnam

Nguyen Tri Phuong Hospital; 🇻🇳 Ho Chi Minh, Vietnam